Earlier this year as Congress wrestled with patent reform, Rep. Debbie Wasserman Schultz (D-FL) offered an amendment to the House of Representatives’ bill that created a safe harbor protection for providers of confirming genetic diagnostic tests from liability for infringement. It was added to the patent bill but with changes from House Judiciary Committee Chair Lamar Smith (R-TX) that Wasserman Schultz sought to reverse.

She and Congress ultimately retreated from pursuing the safe harbor after medical groups and the American Civil Liberties Union (ACLU) complained that the amendment gave test providers too many exemptions. By the time President Barack Obama signed the Leahy-Smith America Invents Act on September 16, the genetic testing safe harbor amendment was watered down into a directive that the U.S. Patent and Trademark Office (USPTO) “conduct a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist.”

That study must be completed by June 16, 2012, and address at least these topics:

The impact of available independent confirming testing on the ability to provide the highest level of medical care to patients and recipients of genetic diagnostic testing and on inhibiting innovation to existing testing and diagnoses.

The impact of current exclusive licensing and patents on genetic testing activity on medicine, including but not limited to interpreting testing results and performing testing procedures.

The roles of cost and insurance coverage on accessing and providing genetic diagnostic tests.

In a post on USPTO’s blog, Janet Gongola, patent reform coordinator, said the agency plans to issue a Federal Register notice in mid-January 2012 requesting written comments and announcing hearing dates for the genetic testing study. “We are planning for hearings in mid-February and our written comment period to run from mid-January to mid-March 2012,” Gongola wrote.

Those hearings are expected to revisit the divide that has emerged between developers that want to keep valuable patent eligibility for their genetic tests and a coalition of medical groups and the ACLU that contend that such eligibility drives up costs, limits patient options, reduces innovation, and harms medical practice.

Two Sides of the Diagnostic Coin

“Because information about gene sequences is so fundamental to understanding the cause, progression, and treatment of disease, patent holders can essentially gain ownership of disease understanding and management through patents,” Mary Steele Williams, executive director of the Association for Molecular Pathology (AMP), told GEN.

“Gene patents serve as a disincentive to innovation, because they deny patients access to vital genetic information that cannot be ‘invented around.’ The threat of litigation for infringing on these patents has created a chilling effect as clinical laboratories and manufacturers of exciting new technologies are reluctant to develop new, improved, and less costly tests that could directly benefit patients.”

A patent attorney whose clients include genetic test developers counters that without the patents, molecular test developers are unlikely to invest the time and money needed to create the screening instruments that doctors and patients need. “If you remove the patent system, the question is, would this test even exist?” David S. Resnick, co-leader of the patents practice group at the law firm Nixon Peabody, told GEN.

“The companies need to recoup their investment and need to profit,” Resnik continued. “The United States doesn’t quite have socialized medicine yet. We’re still in a system where people make an investment, with the expectation that they’re going to make money from it.”

But that sense of ownership by entities whose intellectual property renders them the sole provider of testing around a particular gene sequence or gene-disease association results in them having little incentive to invest in improving their test, according to Williams: “The potential impact on the public health is huge.”

Advocates of independent second-opinion genetic tests have also linked patent eligibility with the high cost of tests and medicines. Developers of diagnostics argue back that the cost issue reflects more the expense of lengthening FDA reviews and the reluctance of insurers to cover expenses of molecular diagnostic tests.

Resnick noted that decisions on patent eligibility should be based on patent law rather than judgments about the value of IP. Section 101, for example, defines as patentable inventions: “Any new and useful process, machine, manufacture, or composition of matter or any new and useful improvement thereof.”

“Who is going to be the arbiter of Section 101? It’s going to be a patent examiner,” Resnick said. “If the examiner sees that the claims are all mental steps, or do not satisfy the machine-or-transformation test, or someone’s trying to patent a human being, then the examiner can give a Section 101 rejection. But to have the examiner be the one who says, ‘this test really is going to hurt society because it’s going to prevent people from getting this test or raise its cost,’ that’s not the job of the Patent Office.”

Do you believe the U.S. can develop a system to protect innovator diagnostic firms but also safeguard those offering confirming tests against patent infringement?

Impending Court Decisions

Both sides in the debate over genetic testing and patentability for molecular diagnostics can agree on at least one point: The U.S. Supreme Court will go a long way toward deciding the issue when it rules next year on Prometheus Laboratories, Inc. v. Mayo Collaborative Services et al. Oral arguments were heard on December 7.

Prometheus v. Mayo concerns the patentability of the methods of dosage calibration for thiopurine drugs for gastrointestinal and nongastrointestinal autoimmune diseases. The methods were designed to account for the context of a treatment regimen based on the individual patient’s metabolism.

“We are hopeful that the eventual ruling helps to force a correction to the errors of the USPTO and concomitant damage inflicted on the public health due to patents on gene sequences and gene-disease associations,” Williams said.

In Prometheus v. Mayo, an amicus curiae filing by Roche Molecular Systems and Abbott Laboratories sheds light on the cost of diagnostic test development: “Bringing a single diagnostic product to market typically requires tens of millions of dollars and can cost well over $100 million under certain circumstances, an investment coupled with several years of research and clinical studies involving hundreds of patients.”

But the amici filing of a medical-healthcare coalition that included AMP maintained that costs would be increased and access to molecular tests wrongly restricted, should Prometheus’ patents be upheld. In such a scenario, the coalition argued, “a laboratory such as Mayo might induce infringement simply by informing a doctor of the correlation in conjunction with delivery of test results or perhaps even by merely publishing articles or brochures discussing the correlation.

“To avoid inducement liability, laboratories would be forced to negotiate and pay license fees to multiple holders of such diagnostic correlation patents and might well decide to forego offering some tests. Moreover, patentees might decide to license their patents only to selected laboratories and physicians, restricting test availability and driving up costs.”

The Supreme Court is also expected to decide another key molecular diagnostic patentability case. In Association for Molecular Pathology v. US Patent and Trademark Office, Myriad Genetics is seeking to protect seven patents related to breast cancer susceptibility genes 1 and 2 and its method for analyzing sequences of those genes for mutations associated with breast cancer.

With the Supreme Court deciding such key cases, not to mention the USPTO report on confirming genetic testing, and next year’s elections, Congress will likely wait and see what the justices and patent office decide rather than get more involved in the issue any time soon. The best outcome for diagnostics developers, doctors, and their patients would be clear guidance from the court and USPTO on what is patentable. Only once this is decided can any discussion and policy on second-opinion genetic testing be properly grounded.

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